Don’t expect a breakthrough technology such as 3D printing or AI-driven medical devices this year. Instead, industry experts anticipate that existing innovative products will gather momentum — among them: devices for minimally invasive procedures, light-therapy-based devices, and human cells, tissues, and cellular and tissue products (HCT/P).
Christopher Devine, Ph.D., president of Devine Guidance International and a MedTech Intelligence columnist, felt positive about the popularity of minimally invasive devices. His forecast was based on what he was seeing with his own clients that are on the leading edge of the design and development of next-generation products (1).
Devine and other medical device experts shared their insights and offered some advice to medtech professionals in the white paper, “Top 5 Medical Device Industry Trends in 2019.”
“Small openings into the body equate to a reduction in the post-surgical infirm and recovery times for patients, regardless of procedure,” said Devine. He cited micro-catheters used to treat peripheral artery disease, radiation-therapy devices for treating breast cancer that require only small incisions, urological-drainage catheters that significantly reduce episodes of urinary tract infections, and next-generation bone screws as examples.
Michelle Lott, principal and founder of Lean RAQA, anticipated an increase in on-indication developments in HCT/P as a result of FDA guidance documents issued at the end of 2017. “We will start to see HCT/Ps with specific on-label indications cleared by the FDA and supported by clinical data. To facilitate biologics license application approvals, the FDA has opened five new pathways to expedite and facilitate review,” she said (2).
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While the FDA considers HCT/P largely as biologics, some products made of HCT/P are regulated as medical devices. They include preserved umbilical cord vein grafts and human collagen. Combination products, such as demineralized bone combined with handling agents and bone-suture-tendon allografts, are also regulated as devices.
In addition to HCT/P, Lott forecasted there will be more medical devices based on light therapy, noting that the number of FDA clearances of such devices has increased. “As the science and understanding behind light-therapy devices grow, we will see novel indications and conditions for unmet needs,” Lott added.
She cited Kyndermed, currently in consideration for a breakthrough designation, as an example. The company has a novel application of light technology that reduces preterm contractions in pregnant women.
Rob Packard, president of Medical Device Academy, said the impact of sensor technology in wearable devices such as watches and patches will not be apparent within the next 12 months, but perhaps within a decade (3).
“The biggest trend I expect in 2019 is a big increase in devices that are not medically necessary,” said Packard, a consultant specializing in 510(k) submissions and helping startup medical device firms address quality and regulatory requirements. “The FDA has already decided not to regulate some of these products, but the technology is pushing the envelope and will exceed the FDA limitations.”
“Medical necessity” is a term used by Medicare, the U.S. federal health insurance for citizens who are 65 or older. The agency doesn’t pay for services, procedures and items that are not medically necessary to diagnose or treat an illness or injury. Under this definition, a surgery to remove skin cancer is a medical necessity, but a face-lift meant to eliminate wrinkles is not.
Packard mentioned devices that “melt” fat, barbed sutures used for face-lifts and diagnostic monitoring devices for healthy people to improve performance as examples of devices that are not medically necessary, but are likely to see growth this year.
(1) Christopher Devine, Ph.D., president of Devine Guidance International, has 32 years of experience in quality assurance, regulatory compliance and program management. His consulting firm specializes in providing solutions for regulatory compliance, quality, supplier management and supply-chain issues facing the medical device industry. He’s a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professionals Society (RAPS) and Project Management Institute. Check out his MedTech Intelligence column
(2) Michelle Lott is the principal and founder of Lean RAQA, a regulatory and quality system solutions company. She has nearly 20 years of health care product experience, including holding executive roles for international regulatory and quality operations. She’s currently serving on the FDA’s Device Good Manufacturing Practices Advisory Committee as an industry representative.
(3) Rob Packard is the president of Medical Device Academy, Inc. He has 25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He has served in senior management positions at several medical device companies, including as president and CEO of a laparoscopic imaging company. His quality management system expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification.
Cindy Fazzi writes about the life science industry and other regulated environments for MasterControl. She has worked as a journalist in three countries. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York City. She has a master’s degree in journalism from Ohio State University.